Lead, It Business Partner - Gxp Validation

Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Their research and close collaboration with the ALS community ultimately resulted in our first commercial product, which is now approved in the U.S. and conditionally approved in Canada.
At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable in the fight against neurodegenerative diseases like, ALS, Alzheimer’s disease, Wolfram Syndrome and others.
Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.
Recent milestones include:

• The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022
• Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022
• 280 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands -- and growing strong!
• AMX0035 is currently under review with the European Medicines Agency

The Opportunity
This role will be responsible for all aspects of IT related to the support of Quality Organization and all GxP Computer System governances. You will function as an IT Business Partner directly supporting the Quality organization which encompasses Quality Systems, Audit, GMP & GCP teams. This role will lead the IT Computer Systems Validation (CSV) execution team engaged in validated testing activities for all projects and change initiatives impacting Amylyx GxP systems. As the leader of this team, you will ensure appropriate validation strategies and resourcing are engaged to maintain validated, scalable, and robust GxP applications required to support growing business needs. Other responsibilities include application maturation and support of Veeva Vault Development Cloud’s Quality Suite. Additional teams you will interact with in these efforts include Regulatory, Pharmacovigilance (Safety), Biometrics, Clinical and Technical Operations teams. This position will encompass many activities including evaluating new functionality while maintaining the integrity of integrated applications; partnering with other members of the IT team, delivering on the business goals, refine existing solutions, and prioritize the day-to-day needs for each of the existing solutions. This is a critical role to support the key functions of Amylyx’s Quality organization.
The Role

• Occasionally manage projects using project management best practices.
• Coordinate issue resolution with internal and external support providers.
• Continuing education focused on new applications and/or functionality to meet organizational growth as additional needs arise.
• Lead Computer System Validation activities and resources as required. Oversee test script creation, user acceptance testing and user documentation for GxP classified systems.
• Introduce best practice and process improvement ideas where appropriate.
• Manage external partners regarding applications and enhancements in line with the overall company objectives and solution capabilities.
• Lead small-group training sessions as needed.
• Support change management and governance activities by partnering with key business users to ensure new items are tested and implemented to meet the business needs.
• Identification, implementation, and support of systems utilized by the Amylyx Quality team.
• Work with other IT team members to maintain roadmap for the integration of Vault platforms with Amylyx (e.g., Commercial CRM, MDM, data warehouse and analytical platforms).
• Elicit, document, and execute on systems strategy and business requirements for each function.
• Develop ad hoc reports up request, using the tools available within the applications based on input from the business.
• Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy.

The Requirements

• Minimum of 6 years of IT experience with progressively increasing technical and support responsibilities.
• Demonstrated ability to manage several complex deliverables at the same time.
• Experience in pharmaceutical/biotech industry GxP regulated functions, including implementing/supporting applications following regulated Computer System Validation protocols.
• Experience implementing CSV strategies, developing and executing UAT testing if GxP systems.
• Bachelor's degree in computer science or related field strongly preferred.
• Experience in interpreting the applicability of local and federal laws/regulations) to company operations.
• Experience in working with Veeva Vault Quality & Development Cloud products is preferred.

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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.